治験一覧
8,963 件中 1081〜1100 件を表示
健康な成人男性ボランティアにおけるSTN1012600点眼液の薬物動態学的研究
To evaluate the safety and plasma pharmacokinetics of STN1012600 ophthalmic solution 0.002% (1 drop once daily for 7 days) in healthy adult male subjects.
全身性重症筋無力症（gMG）の試験参加者によるロザノリキシズマブの自己投与を評価する第3相オープンラベルクロスオーバー試験
The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.
固形腫瘍患者を対象としたROSE12単独および他の抗腫瘍剤との併用療法の第I相試験
This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.
片頭痛のある小児（6～17歳）を対象とした経口アトゲパント錠の有害事象を評価する長期継続試験
A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for participants less than 18 years of age. The main goal of the study is to evaluate the long-term safety and tolerability of atogepant in pediatric participants between the ages of 6 and 17 with migraine. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of migraine. This is a Phase 3, open-label study of atogepant in participants with a history of migraine. Participants must have completed participation in another study of atogepant (lead-in study). Participants must have 4 to 14 migraine days and less than 15 headache days for episodic migraine, and \>= 15 headache days and \>= 8 migraine days for chronic migraine in the 4-week screening electronic diary (eDiary; similar to a smart phone). Around 650 participants will be enrolled in the study at approximately 100 sites worldwide. Atogepant is a tablet taken once a day by mouth. Participants between the ages of 12 and 17 will receive high dose atogepant for 52 Weeks. Participants between the ages of 6 and 11 will receive an atogepant dose determined in the lead-in study for 52 Weeks. There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
プラチナ製剤、エトポシド、デュルバルマブ併用療法後の進展期小細胞肺癌（ES-SCLC）の第一選択治療におけるタルラタマブとデュルバルマブの併用とデュルバルマブ単独の併用を比較する試験
The primary objective of this study is to compare the efficacy of tarlatamab plus durvalumab with durvalumab alone on prolonging overall survival (OS).
H1抗ヒスタミン薬への反応が不十分なCSUの12～18歳青年を対象としたLOU064の有効性、薬物動態、安全性を評価する24週間の二重盲検ランダム化プラセボ対照試験。その後、任意の3年間のオープンラベル延長試験と任意の3年間の安全性長期無治療追跡調査を実施。
The purpose of this trial is: 1. to assess the efficacy, pharmacokinetics, and safety of remibrutinib vs. placebo in adolescents from 12 to \< 18 years of age suffering from chronic spontaneous urticaria inadequately controlled by H1-antihistamines 2. to collect long-term efficacy, safety and tolerability data on remibrutinib in adolescents after having completed 24 weeks of treatment 3. to collect safety data in this population for up to three years after the last dose of study treatment
再発性または難治性の多発性骨髄腫または既治療のアミロイド軽鎖（AL）アミロイドーシス患者を対象としたJNJ-79635322の研究
The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\[s\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).
中等度から重度のアトピー性皮膚炎の成人患者を対象としたLY3454738の治療試験
The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).
局所進行性または転移性固形腫瘍患者におけるHER3-DXdの研究
This is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
ADH1患者における標準治療と比較したエンカレレットの有効性と安全性
The primary purpose of the study is to understand the effectiveness, safety, and tolerability of encaleret when compared to standard of care (SoC) treatment in participants with Autosomal Dominant Hypocalcemia Type 1 (ADH1).
脂質異常症患者におけるAZD0780の異なる用量の有効性、安全性および忍容性を評価する研究
The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.
切除不能な局所進行頭頸部扁平上皮癌患者を対象とした、根治的同時化学放射線療法後のVolrustomig（MEDI5752）の国際共同試験
The main purpose of this study is to assess the efficacy and safety of volrustomig compared to observation in participants with unresected locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent chemoradiotherapy (cCRT).
FFRangio冠動脈生理学的評価によるカテーテル検査室の成果向上
To test whether FFRangio-guided treatment is non-inferior to conventional pressure wire-guided treatment in patients with coronary artery disease.
肥大型心筋症患者の健康関連QOLを評価する研究
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases. Phase I is a qualitative study using semi-structured in-depth interviews in participants with hypertrophic cardiomyopathy. Phase II is a quantitative study using questionnaires in participants with hypertrophic cardiomyopathy and a control group of participants who do not have hypertrophic cardiomyopathy.
SPECTRUM試験：アフリベルセプト8mgが新生血管性加齢黄斑変性症または糖尿病性黄斑浮腫による視力障害の治療にどの程度有効であるかを詳細に調べる観察研究
これは、主治医からアフリベルセプト8mgを既に処方されている方のみからデータを収集する観察研究です。 本研究では、新生血管性加齢黄斑変性症（nAMD）または糖尿病黄斑浮腫（DME）による視力障害のある成人のデータを収集し、研究します。 視力障害とは、日常生活に支障をきたす程度の視力低下を指します。nAMDは、異常な血管が増殖し、網膜の中心部である黄斑に血液または網膜液が漏れ出すことで視力低下を引き起こす眼疾患です。nAMDは、50歳以上の人の視力低下の主な原因です。DMEは糖尿病に関連する眼疾患です。DMEでは、損傷した血管からの液漏れにより黄斑が腫れ、視力障害を引き起こします。 アフリベルセプト8mgは、眼内に注射する薬剤です。この薬は、眼底の血管の異常な増殖と漏出を引き起こす血管内皮増殖因子（VEGF）と呼ばれるタンパク質を阻害することで効果を発揮します。 アフリベルセプト8mgは、PHOTON試験とPULSAR試験という2つの試験結果に基づき、nAMDおよびDMEによる視力障害の治療薬として承認申請されています。この試験は、承認取得後すぐに開始されます。現在、アフリベルセプト8mgに関する実臨床データはありません。 この試験の主な目的は、nAMDおよびDMEの患者におけるアフリベルセプト8mg注射剤の有効性に関するより多くの情報を収集することです。この試験には、nAMDまたはDMEの治療歴のない参加者と、過去に治療を受けた参加者が参加します。 研究者が収集する主な情報： 治療開始12ヶ月後の最高矯正視力（BCVA）と呼ばれる視力検査スコアの変化 データは2024年2月から2027年9月まで収集され、参加者1人あたり最大24ヶ月間にわたります。データは、診療記録および日常診療における定期診察時の患者への聞き取り調査によって収集されます。 研究者は、アフリベルセプト8mgの初回投与から観察期間終了まで、参加者を観察します。 本研究では、定期診察から得られた利用可能なデータのみを収集します。本研究の一環として、診察や検査は必要ありません。
進行固形腫瘍患者を対象としたSTX-478の単剤療法および他の抗腫瘍剤との併用療法に関するヒト初回臨床試験
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
GnRH-aによる子宮内膜症の血管新生への影響
Purpose: Neo-angiogenesis is necessary for adhesion and invasiveness of endometriotic lesions in women affected by endometriosis. VEGF is one of the major components of angiogenesis and is part of the major pathway TF-PAR-2-VEGF that leads to neo-angiogenesis. SP1 is a transcriptional factor that has lately been studied for its crucial role in angiogenesis, via a distinct pathway. We hypothesize that by blocking angiogenetic pathways we can repress endometriotic lesions. GnRH-agonists are routinely used, especially pre-operatively, in endometriosis. It would be interesting to clarify which angiogenetic pathways are affected and pave the way for further research over anti-angiogenetic effects on endometriosis. Methods: We used qRT-PCR to study mRNA expression levels of TF, PAR-2, VEGF and SP1 in endometriotic tissues of women who underwent surgery for endometriosis and received GnRH-a \[leuprolide acetate\] preoperatively.
ICU LIBERATION研究
Acute respiratory distress syndrome (ARDS) is a condition associated with hypoxemia due to noncardiogenic causes and results in high mortality. However, the epidemiology and treatment strategy for ARDS may have changed significantly due to the accumulation of a large body of knowledge, following the two-year pandemic of the novel coronavirus (SARS-CoV-2) of which the primary manifestation is ARDS. To improve the quality of ICU care that patients receive after admission to the ICU, a variety of academic societies, including the Japanese Society of Intensive Care Medicine and the Society of Critical Care Medicine, are currently developing evidence-based guidelines and consensus guidelines and statements regarding ABCDEF bundles, nutritional therapy, ICU diary. The ABCDEF bundle, nutritional therapy, and ICU diary have been developed and are being promoted for implementation in hospitals around the world. The implementation of evidence-based ICU care is strongly recommended, especially for patients with acute respiratory distress syndrome who frequently require ventilators to maintain their lives, because their patient outcomes are worse than those who were admitted to ICU with other causes. However, there is still little evidence on how the quality of ICU care (compliance rate) correlates with patient prognosis and outcomes, and there are currently no clear goals or indicators for the ICU care we should develop. This study aims to investigate the epidemiology and treatments given to the patients and evaluate the implementation of evidence-based ICU care and its association with the outcomes of patients with acute respiratory distress syndrome admitted to the ICU. The contents of mechanical ventilation settings, respiratory conditions, and the evidence-based ICU care, such as analgesia, sedation, rehabilitation, and nutrition, given to the patients will be collected in a daily basis. Aim 1: Epidemiology Aim 2: Treatments Aim 3: Evidence-based ICU care Aim 4: ARDS related Post Intensive Care Syndrome
切除された黒色腫患者におけるABP 206とオプジーボ®（ニボルマブ）の類似性を評価する研究
The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of ABP 206 compared with OPDIVO® (nivolumab) in subjects with resected advanced melanoma.
近視性脈絡網膜萎縮症（PAMyCA）患者を対象としたPAL-222の臨床試験
The goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy. The main question it aims to answer are: • Percentage of changes in the chorioretinal atrophic area Participants will be implanted one sheet of PAL-222 into the subretinal space through pars plana vitrectomy. Researchers will compare non-therapeutic eye to see if the changes is significant different.